Catalog Number

-

Brand Name

Tech Medical Services

Version/Model Number

TMS233050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103508,K103508

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

fef0a5fe-b07d-41af-b47e-ef0fa22bae81

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 27, 2021

Package DI Number

10851695005293

Quantity per Package

10

Contains DI Package

00851695005296

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box